Senior Data Manager

Vor Bio•Boston, MA

18d•$175,000 - $190,000

About The Position

Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide. When you join Vor, you’re not just working on a medicine. You’re part of a mission to redefine the future of autoimmune care. Why Work at Vor? Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases. Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond. Innovation: Work on a platform with potential beyond one indication — a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren’s syndrome. Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies. The Senior Data Manager is responsible for all data management activities from study start-up through database lock and archiving and independently supporting the needs of the clinical study and programs of studies. The Senior Data Manager will ensure completeness, accuracy and consistency and meet the standards of quality analysis and reporting to regulatory bodies. In addition, the Senior Data Manager has an active role in continuous improvement and acts as a leader in the department as demonstrated by successful mentoring and consistent study delivery over time.

Requirements

Bachelor's Degree in programming, health-related sciences, or relevant field and 7+ years of Data Management experience.
In depth knowledge of industry leading eCRF tools and well versed in industry trends and emerging technologies supporting data collection.
Knowledge of clinical research, FDA & ICH, GCP, GCDMP, related regulatory requirements.
Proven direct experience with data management tasks as well as DM vendor oversight to meet aggressive timelines of high-quality data deliverables.
Analytical and problem-solving capabilities
Excellent verbal and written communication skills.
Professional attitude and strong interpersonal skills.
Ability to work well with a multi-disciplinary team of professionals.
Flexible attitude with respect to work assignments and new learning.
Ability to prioritize workload.
Superior attention to detail.
Understanding of clinical research and the relationship of Data Management in the clinical study process.
Strong technical aptitude and ability to adapt to multiple data management platforms.
Strong knowledge of electronic data capture (EDC) clinical data management systems.
Strong computer skills (Microsoft Office Suite, Medidata Rave) and ability to understand and adapt to various information technology (IT) systems.

Responsibilities

Serves as data lead for one or more clinical trials, assuming responsibility for all data management activities, including access levels and permissioning
Conduct oversight of data management activities performed by the CROs and other 3rd party vendors (IRT, Safety, Lab, etc.) to meet Vor's obligations and business objectives throughout study (ies) life cycle i.e. from protocol synopsis through database release and submission.
Ensure the CRO and other internal and external partners align and conform to data management expectations for the assigned compound and/or indication.
Participate in the creation of the clinical development plan, describing the clinical development strategy and possible innovative trial designs.
Proactively drive quality and efficiency set quality expectations and timelines for data management deliverables and regularly follow up on data management milestones. Ensure inspection readiness at all times.
Set expectations and communicate and a transparent, clear way and motive team members to work towards achieving the clinical goals.
Follow department and company standard operating procedures (SOPs), forms, templates and policies. Provide feedback and update these guidelines as needed.
Develop, review, and maintain all study Data Management documentation.
Coordinate with Database Developers to ensure effective database build and timely go-live to meet the needs of the project.
Ensure the clinical database adheres to Clinical Data Acquisition Standards Harmonization guidelines allowing for optimal SDTM dataset programming. Suggest design for standard and non-standard data collection, identify any gaps in data collection, and challenge collection of unnecessary data.
Plan, perform and oversee development of specifications for eCRFs, edit checks, electronic data handling, manual review, and execution of User Acceptance Testing in collaboration with CROs and relevant functional partners Define electronic case report form (eCRF) and edit check specifications to support data collection and analysis required per protocol.
Manage end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors to ensure deliverables are on time and of high quality.
Work with the CRO to ensure all data cleaning tools are in place for EDC, IRT, SAE and all external data sources to ensure consistency, accuracy, and integrity of clinical dataTake responsibility for and guide effective quality control (QC) review and user acceptance testing (UAT) of the clinical database prior to its release into production, including oversight of staff performing these tasks.
Ensure data are properly reviewed in accordance with the Data Management Plan (DMP) and guidelines and that cleaning is effective and timely.
Provide input on study timelines, identify risks, and communicate mitigation strategies to the Project Manager.
Provide input into improving the efficiency of data management tasks.
Lead and participate in intradepartmental or interdepartmental process and quality improvement initiatives.